# K141211: Inclusive Titanium Abutments Compatible with Straumann Tissue Level Implants

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Oct 22, 2014 after 166 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894595 (1990). 70 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033243: Iti Synocta Meso Abutments, Straumann USA (2003) Summary page 5.
- K083192: Inclusive Titanium Abutment Blanks, Inclusive Dental Solutions (2009) Summary page 5.

## Most influential descendants
- K151798: Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System (2015), 0 descendants of its own

## Indications for use
Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive Titanium Abutments are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes.

Source page: https://510kreport.com/device/K141211
Methodology: https://510kreport.com/methodology